The Effect of Chan-Chuang Qigong on Fatigue, Exercise Capacity and Quality of Lifpatients With Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure NYHA Class II
• Interventions: Behavioral: Chan-Chuang qigong

• Registration Number: NCT06521281
• Lead Sponsor: Chia-Lin Hsieh

Brief Summary

This study aimed to investigate the impact of Chan-Chuang Qigong on fatigue, exercise capacity, quality of life, and heart function in heart failure patients. The study recruited 72 heart failure patients from a medical center in northern Taiwan for an experimental study. The participants were randomly divided into two groups: patients in experimental group was given twice daily, every 15 minutes Chan-Chuang qigong, control group received the regular care for heart failure patients. Data was collected using the Piper Fatigue Scale, a six-minute walking test, and the Minnesota Living with Heart Failure Questionnaire before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention. It is hoped that through this study, we can understand the effect of Chan-Chuang qigong on improving fatigue, exercise capacity and quality of life in patients with heart failure, and provide an additional choice and reference for the treatment and care of patients with heart failure in the future, and recommend future treatment of heart failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-16
• Primary Completion: 2023-11-25
• Study Completion: 2023-11-25
• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. at least 20 years of age.
2. Cardiology specialist diagnoses heart failure based on clinical examination
3. Heart failure classified as New York Heart Association class II (NYHA II)
4. Left ventricular ejection volume <50% (HFmrEF and HFrEF)
5. According to the doctor's assessment, it is not appropriate to exercise
6. Clear consciousness and ability to communicate
7. Agree to participate in this study after explanation and sign the consent form

Exclusion Criteria

1. Renal failure treated with hemodialysis
2. Severe arrhythmias, such as third-degree atrioventricular block, frequent ventricular pulses and heartbeats greater than 130 beats/min at rest
3. About to undergo coronary interventional surgery or cardiac surgery within 3 months
4. Coronary interventional surgery or cardiac surgery in the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
qigong group	Chan-Chuang qigong	Patients in qigong group was given twice daily, every 15 minutes Chan-Chuang qigong

Primary Outcome Measures

Name	Time	Method
Use the Chinese version of Piper fatigue scale to assess fatigue levels.	before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention	Use the Chinese version of Piper fatigue scale.There are 16 questions in total. Based on a four-point Likert scale, the minimum score is 16 points and the maximum total score is 64 points. The higher the score, the more serious the fatigue.
Use the Six Minute Walking Distance (6MWD) to assess the patient's exercise capacity.	before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention	Use the Six Minute Walking Distance (6MWD) to assess the patient's exercise tolerance by measuring the distance the patient walks in a straight line on a surface above 30 meters for 6 minutes.
Use the Chinese version of the Minnesota Heart Failure Quality of Life to assess quality of life.	before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention	Use the Chinese version of the Minnesota Heart Failure Quality of Life Questionnaire.There are 21 questions in total, scored from 0 to 5, with a total score of 105. The higher the score, the more serious the impact of the disease on life.

Secondary Outcome Measures

Name	Time	Method
heart function-Left ventricular ejection volume	before the intervention as the baseline, and the twelfth week of intervention respectively	Left ventricular ejection volume were collected by reviewing medical records.
heart function-Serum NT-pro BNP values	before the intervention as the baseline, and the twelfth week of intervention respectively	Serum NT-pro BNP values were collected by reviewing medical records.

Trial Locations

Locations (1)

Hsieh Chia Lin; 🇨🇳 Taipei, Taiwan